bbi solutions - contract services

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Contract Services

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Page 1: BBI Solutions - Contract Services

Contract Services

Page 2: BBI Solutions - Contract Services

Fast

Results

Regulated

Markets Competition

High

Sensitivity

Today’s lateral flow challenges

2nd

generation

DX

Quantitative

tests with

readers

Increased

accuracy Price

Page 3: BBI Solutions - Contract Services

25 years experience developing lateral flow

assays, BBI is a name you can trust

Quality - FDA and ANVISA registered

manufacturing sites. ISO13485 and

ISO9001 certified QMS systems across

sites

Innovation - Sensitivity enhancement

technology, award winning platforms,

mobile reader solutions

Partnership – The design history folder

belongs to you

Experience – Multiple platforms and

particles

Results – Outputs agreed at the start,

ensure you get the results you demand

Next generation assay development

“We have successfully

completed more than

250 different lateral flow

projects under regulated

conditions and FDA

design control”

Page 4: BBI Solutions - Contract Services

Depending on the complexity of the assay, a typical development project can run

from 12-24 months and will work as follows:

Our flexible turnkey approach

Our turnkey approach means you’re not locked in

A dedicated team of scientists work on your product alone

We hand over the design history file to you

Page 5: BBI Solutions - Contract Services

Our skills and capabilities

Veterinary

Environmental

Medical diagnostics

Agriculture

Military

Food safety

Blood banking

Companion diagnostics

Whole, blood, serum or plasma

Urine

Saliva

Other body fluids

Milk

Fuel

Food

Culture media

Sample Matrices

Markets

25 years experience delivering high performance assays for different applications

Page 6: BBI Solutions - Contract Services

Our skills and capabilities

Fluorescence

Latex

Molecular

Enzymes

Gold / Silver / Platinum

Paramagnetic

Single or multi analyte

Antibody or antigen sandwich

Competitive

Qualitative

Semi quantitative

Qualitative tests / readers

Assay formats

Detection technologies

Using the right platforms and particles to deliver fast, accurate results

Page 7: BBI Solutions - Contract Services

Novarum uses smartphone based software

which can be developed to read any lateral flow

test

Provide quantitative analysis without

changing platforms

Connect end users to results instantly

Increase the accuracy of the result by

removing human error

Improve performance with an immediate

pass / fail result

Be seen as an innovator and leader

in the market

Next generation reader solution

“Improve performance

and extend the life of

your assay using our

revolutionary solution”

Page 8: BBI Solutions - Contract Services

Innovative platforms for fast, accurate results

A World First – Award Winning AtomoRapid™ Platform

Integrated blood sample collection platform simplifies test

procedures, improves safety and reduces errors

= improved accuracy of result

Direct delivery of plasma onto the membrane allows our POCkit

platform to increase sensitivity. It can also reduce your

development time by up to six months!

IMASS – Fast Results for up to 8 Targets

Integrated Multiplex Assay and Sampling System device allows users to

sample directly onto the device and run multiple tests simultaneously

=Fast, robust and easy-to-use solution for rapid testing

Page 9: BBI Solutions - Contract Services

Improve the accuracy of your result with

our integrated blood sample collection

platform, AtomoRapid™

Why AtomoRapid™?

AtomoRapid™ is an easy to use, all in

one device that greatly simplifies test

procedures

Reduces complexity & the number of test

components, AtomoRapid™ improves

safety and reduces the risk of

contamination

Provides greater control and helps

overcome common user errors

A World First - AtomoRapid™ Platform

“User friendly and fool

proof, reducing errors

& improving accuracy

of result”

Feedback from Clinical nurse on AtomoRapid™

Page 10: BBI Solutions - Contract Services

POCkit is a serological platform that

discriminates between two antigenically

similar analytes

Why POCkit™?

Compatible with a range of biologicals

including whole blood, serum, plasma

and oral fluid

Patented pre-absorption feature reduces

‘Hook Effect’

Integrated sample separation

In-line blood separation technology

Direct delivery of plasma onto the

membrane reduces ‘dead volume’ and

increases sensitivity

Increase sensitivity with POCkit™

“Increase specificity

without affecting the

sensitivity of your

assay ”

Page 11: BBI Solutions - Contract Services

Our IMASS (Integrated Multiplex Assay and

Sampling System) device is a fast, robust

and easy-to-use solution for rapid testing

Why IMASS?

Sample directly onto the device

Multiple assay sticks run simultaneously

from a single sample

Fast results for up to 8 targets

simultaneously in 15 minutes

Ergonomic patented design is easy to

use

Reduce error with easy to read by eye

results

Assay strips can be custom developed

IMASS – fast, accurate results in the field

“BBI’s IMASS device

provides a crucial

advance in rapid

testing”

Page 12: BBI Solutions - Contract Services

Outsource to the experts in lateral flow

+ Reagent dispensing

+ Rapid test device assembly

+ Product packaging

+ Functional QC testing

+ Process validations

+ Product improvements

+ Semi automation

Time efficient and cost effective with

transfers completed in 3-4 months

Quality – FDA and ANVISA registered

manufacturing sites. ISO13485 and

ISO9001 certified QMS systems across all

sites

Flexible options – catering for spiked

demand and technically challenging

manufacture

Reliable Supply – We have over 60 assays

in routine manufacture across 4 global sites

Results – Support those problematic

assays and smooth your supply

Page 13: BBI Solutions - Contract Services

World class manufacturing facilities

30,000 sq feet for manufacturing

Capacity of 10-15 million assays

5 to 100K+ device batch sizes

Facilities located in the UK (Cardiff and

Dundee), USA (Madison) and South

Africa (Cape Town)

ISO13485 and ISO9001 certified QMS

systems across all sites

“We have FDA and

ANVISA registered

manufacturing sites”

Page 14: BBI Solutions - Contract Services

Control quality, save time and money with our

machinery solutions

IsoFlow Bench-top Reagent Dispenser Ideal for laboratory R&D use and small scale manufacture

100,000 test per day capacity

6 programme memory

Hand held digital operation

Application of 1-8 reagent lines

Accepts all membrane or card types

IsoFlow Reel-to-Reel Reagent Dispenser Ideal for large scale manufacture

Capacity to produce over 800m, approximately 2m/minute of

material per day

1000+ metres per day output

Reel-to-reel Striping/spraying

Dispensing range of 0.01 to 10 μl/mm

6 programme memory